NCT06735430

Brief Summary

a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 9, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 4, 2024

Last Update Submit

December 25, 2025

Conditions

Pediatric HerniaLaparoscopic SurgeryAppendicitis, Surgery

Keywords

CiprofolPropofolTotal Intravenous AnesthesiaChildren

Outcome Measures

Primary Outcomes (1)

  • Extubation time

    Time interval between drug withdrawal and removal of the tracheal catheter

    up to 1 hour

Secondary Outcomes (5)

  • Aldrete Score

    up to 2 hours

  • Emergence Agitation

    up to 2 hours

  • Postoperative Pain

    24 hours

  • Postoperative nausea and vomiting

    24 hours

  • satisfaction degree

    24 hours

Study Arms (2)

Ciprofol

EXPERIMENTAL

Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))

Drug: Ciprofol

Propofol

OTHER

Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Drug: Propofol

Interventions

CiprofolDRUG

Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))

Ciprofol
PropofolDRUG

Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))

Propofol

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • laparoscopic surgery under general anesthesia

You may not qualify if:

  • Known allergies to propofol and ciprofol,
  • Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
  • uncooperate with peripheral venipuncture and catheterization;
  • History of acute upper respiratory tract infection in the past 2 weeks;
  • With severe respiratory, circulation, liver and kidney insufficiency;
  • Body mass index (BMI) of 30 kg/m² or 15 kg/m²;
  • Known long-term use of sedative drugs;
  • ASAⅢ grade or above;
  • recent participation in other clinical studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Appendicitis

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenolPropofol

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • mujun Chang, Dr.

    Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 16, 2024

Study Start

March 9, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)